Methods and products for inducing mucosal immunity

Abstract

The invention relates methods and products for inducing mucosal immunity. In particular, the invention relates to the use of immunostimulatory oligonucleotides containing a CpG motif for inducing mucosal immunity. The CpG immunostimulatory oligonucleotides may be administered alone or in combination with antigen and/or with other adjuvants.

We claim:  
     
         1 .- 124 . (Cancelled)  
     
     
         125 . A composition comprising 
 an oral formulation of an effective amount of an immunostimulatory CpG oligonucleotide 8-100 nucleotides in length comprising                                      5′ X1X2CGX3X4 3′,                                 and a pharmaceutically acceptable carrier,    wherein at least the C of the 5′CG3′ is unmethylated and X1, X2, X3 and X4 are nucleotides,    wherein the pharmaceutically acceptable carrier comprises dyestuffs, pigments, sugars, agar, sodium alginate or gum arabic, and    wherein the immunostimulatory CpG oligonucleotide is isolated or synthetic.    
     
     
         126 . The composition of  claim 125 , wherein the pharmaceutically acceptable carrier comprises dyestuffs.  
     
     
         127 . The composition of  claim 125 , wherein the pharmaceutically acceptable carrier comprises pigments.  
     
     
         128 . The composition of  claim 125 , wherein the pharmaceutically acceptable carrier comprises sugars.  
     
     
         129 . The composition of  claim 125 , wherein the pharmaceutically acceptable carrier comprises agar.  
     
     
         130 . The composition of  claim 125 , wherein the pharmaceutically acceptable carrier comprises sodium alginate.  
     
     
         131 . The composition of  claim 125 , wherein the pharmaceutically acceptable carrier comprises gum arabic.  
     
     
         132 . The composition of  claim 125 , wherein the immunostimulatory CpG oligonucleotide comprises the sequence  
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                   5′ X1X2CGX3X4 3′, 
                     
                 
                     
                     
                 
             
                
                
                
               
            
           
         
       
       wherein X1 or X2 or both are purines and X3 or X4 or both are pyrimidines.  
     
     
         133 . A method for treating a subject having an infection comprising 
 administering to a subject having an infection an immunostimulatory CpG oligonucleotide 8-100 nucleotides in length comprising                                      5′ X1X2CGX3X4 3′,                                 and a pharmaceutically acceptable carrier,    wherein at least the C of the 5′CG3′ is unmethylated and X1, X2, X3 and X4 are nucleotides, and    wherein the infection is selected from the group consisting of enterovirus infection, calciviridae infection, vesicular stomatitis viral infection, rotavirus infection,  Salmonella  spp. infection,  Helicobacter pyloris  infection and  M. intracellulare  infection.    
     
     
         134 . The method of  claim 133 , wherein the immunostimulatory CpG oligonucleotide comprises the sequence  
       
         
           
                 
                 
                 
               
                     
                     
                 
                     
                   5′ X1X2CGX3X4 3′, 
                     
                 
                     
                     
                 
             
                
                
                
               
            
           
         
       
       wherein X1 or X2 or both are purines and X3 or X4 or both are pyrimidines.  
     
     
         135 . The method of  claim 133 , wherein the infection is Helicobacter pyloris infection.  
     
     
         136 . The method of  claim 133 , wherein the infection is calciviridae infection.  
     
     
         137 . The method of  claim 133 , wherein the immunostimulatory CpG oligonucleotide is 8-40 nucleotides in length.  
     
     
         138 . The composition of  claim 125 , wherein the immunostimulatory CpG oligonucleotide is 8-40 nucleotides in length.  
     
     
         139 . The method of  claim 133 , wherein the ‘5CG3’ is not part of a palindrome.  
     
     
         140 . The composition of  claim 125 , wherein the ‘5CG3’ is not part of a palindrome.  
     
     
         141 . The method of  claim 133 , wherein the immunostimulatory CpG oligonucleotide includes a phosphorothioate backbone modification.  
     
     
         142 . The composition of  claim 125 , wherein the immunostimulatory CpG oligonucleotide includes a phosphorothioate backbone modification.  
     
     
         143 . The method of  claim 133 , wherein the oligonucleotide is orally administered.